Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidină - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - agenți antineoplazici - azacitidina accord este indicat pentru tratamentul pacienților adulți care nu sunt eligibili pentru transplant de celule stem hematopoietice (tcsh) cu:- intermediar-2 și de mare risc sindroame mielodisplazice (smd) potrivit international de prognostic scoring system (ipss),- cronica leucemia mielomonocitară (lmmc) cu 10-29 % blaști în măduva fără tulburări mieloproliferative,- leucemie mieloidă acută (lma) cu 20-30 % blaști și multi-lineage displazie, potrivit organizației mondiale a sănătății (oms) clasificarea,- aml cu >30% blaști în măduva în conformitate cu clasificarea oms.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridine - scleroză multiplă - alte medicamente pentru sistemul nervos - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - agenți antitrombotici - prevenirea tromboembolismului venos (vte) la pacienții adulți supuși unei intervenții chirurgicale de înlocuire a șoldului sau a genunchiului. tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți. (see section 4. 4 for haemodynamically unstable pe patients. tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți. (see section 4. 4 pentru haemodynamically instabil pe pacienți). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 și 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. tratamentul trombozei venoase profunde (tvp) și embolie pulmonară (ep), și prevenirea tvp și ep recurente la adulți. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - acetat de abirateron - prostate neoplasme - terapia endocrină - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - imunostimulante, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostate neoplasme - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazol - micozele - antimicotice pentru uz sistemic - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractară este definită ca progresie a infecției sau eșecul de a îmbunătăți dupa o perioada de minim 7 zile înainte de eficient la doze terapeutice tratamentul antifungic. posaconazole accord este, de asemenea, indicat pentru profilaxia infecțiilor fungice sistemice la următorii pacienți: pacienții care au primit iertarea-chimioterapie de inducție pentru leucemie mieloidă acută (lma) sau în sindroamele mielodisplazice (smd) de așteptat apariția neutropeniei prelungite și care prezintă un risc ridicat de a dezvolta infecții fungice invazive;transplant de celule stem hematopoietice (tcsh) beneficiarii care sunt în curs de doze mari de terapie imunosupresoare pentru boala grefă contra gazdă și care sunt la risc ridicat de a dezvolta infecții fungice invazive.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - tigeciclina - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibacteriene pentru uz sistemic, - tygecycline accord este indicat la adulți și la copii de la vârsta de opt ani, pentru tratamentul următoarelor infecții (vezi secțiunile 4. 4 și 5. 1):complicate ale pielii și țesuturilor moi infecții (cssti), cu excepția infecții ale piciorului diabetic (a se vedea secțiunea 4. 4)infecții intra-abdominale complicate (ciai)tygecycline acord ar trebui să fie utilizate numai în situațiile în care alte alternative antibiotice nu sunt potrivite (a se vedea secțiunile 4. 4, 4. 8 și 5. trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetul zaharat, tip 2 - medicamente utilizate în diabet - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 și 5. 1 pentru datele disponibile pe diferite combinații).

Europäische Union - Rumänisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - agenți antineoplazici - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.